卡维地洛片治疗慢性收缩性心力衰竭的临床研究

Clinical trial of carvedilol tablets in the treatment of chronic systolic heart failure

目的观察卡维地洛片治疗慢性收缩性心力衰竭的临床疗效及安全性。方法将90例慢性收缩性心力衰竭患者随机分为对照组和试验组,每组45例。对照组予以利尿、强心、血管紧张素转化酶抑制药、洋地黄等常规治疗;试验组在对照组治疗的基础上,予以卡维地洛,初始剂量2.25 mg,最大耐受量为25 mg,qd,口服。2组患者均治疗3个月。比较2组患者的临床疗效、左心室舒张末期内径(LVEDD)、左心室射血分数(LVEF)和最大摄氧量,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为91.11%(41例/45例)和68.89%(31例/45例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的LVEDD分别为(45.72±3.58)和(54.98±3.89)mm,LVEF分别为(51.32±2.62)%和(42.85±3.24)%,心室收缩同步性分别为(91.00±6.13)和(105.17±9.58)ms,最大摄氧量分别为(24.47±0.98)和(17.86±1.37)mL·kg·min^(-1),差异均有统计学意义(均P<0.05)。试验组治疗过程中发生的药物不良反应主要有恶心呕吐、胸痛和低血压,对照组发生的药物不良反应主要有恶心呕吐。试验组和对照组的总药物不良反应发生率分别为6.67%和2.22%,差异无统计学意义(P>0.05)。结论卡维地洛片治疗慢性收缩性心力衰竭的临床疗效确切,其能明显改善患者的心功能和最大摄氧量,且不增加药物不反应的发生率。

Objective To observe the clinical efficacy and safety of carvedilol tablets in the treatment of chronic systolic heart failure.Methods A total of 90 patients with chronic systolic heart failure were randomly divided into control and treatment groups with 45 cases per group. Control group was treated with diuretic,cardiac,angiotensin-converting enzyme inhibitor and digitalis. Treatment group was combined with carvedilol,the initial dose was 2. 25 mg,the maximum tolerated dose was 25 mg,qd,orally. Two groups were treated for 3 months. The clinical efficacy,left ventricular end diastolic diameter（ LVEDD）,left ventricular ejection fraction（ LVEF） and maximal oxygen uptake,and adverse drug reactions were compared between two groups. Results After treatment,the total effective rates of treatment and control groups were 91. 11%（ 41 cases/45 cases） and 68. 89%（ 31 cases/45 cases）with significant difference（ P〈0. 05）. After treatment,the main indexes of treatment and control groups were compared： LVEDD were（ 45. 72 ±3. 58） and（ 54. 98 ± 3. 89） mm,LVEF were（ 51. 32 ±2. 62） %and（ 42. 85 ± 3. 24） %, the ventricular systolic synchrony were（ 91. 00 ± 6. 13） and（ 105. 17 ± 9. 58） ms,the maximal oxygen uptake were（ 24. 47 ± 0. 98） and（ 17. 86 ± 1. 37）mL·kg·min^-1,the differences were statistically significant（ all P〈0. 05）. The adverse drug reactions of treatment group were nausea and vomiting,chest pain and hypotension,which in control group were nausea and vomiting. The total incidences of total adverse drug reactions in the treatment and control groups were 6. 67% and 2. 22% without significant difference（ P〉0. 05）. Conclusion Carvedilol tablets have a definitive clinical efficacy in the treatment of chronic systolic heart failure,which can effectively improve the ventricular systolic synchrony and maximal oxygen uptake,without increasing the incidence of adverse drug reactions.